Data back use of AZ and Pfizer COVID-19 vaccines in older people

 Both the Pfizer/BioNTech and Oxford University/AstraZeneca COVID-19 vaccines are highly effective in reducing COVID-19 infections among older people, according to an emerging study data.

Data came from Public Health England, which has submitted findings of a real-world study for peer review.

The article compares the rate of vaccination in symptomatic people aged over 70 years of age who test positive for COVID-19, compared to those who test negative.

It compares the rate of hospitalisation in confirmed COVID-19 cases aged over 80 who were vaccinated more than 14 days before testing positive, compared to unvaccinated cases.

The study also compares the rate of deaths in confirmed COVID-19 cases aged over 80 who were vaccinated with Pfizer vaccine more than 14 days before testing positive, compared to unvaccinated cases.

Findings show that protection against symptomatic COVID, four weeks after the first dose, ranged from between 57-61% for one dose of the Pfizer shot and 60-73% from the AZ vaccine.

In the over 80s, data suggest that a single dose of either vaccine is more than 80% effective at preventing hospitalisation, around 3 to 4 weeks after the jab.

There is also evidence for the Pfizer vaccine, which suggests it leads to an 83% reduction in deaths from COVID-19.

The data could have implications for countries that have decided not to recommend or approve the AZ vaccine for use in older people.

Many EU countries in the EU have restricted use of the AZ vaccine in older people, citing a lack of evidence in the first studies used for approval as these included a high proportion of younger people for ethical reasons.

The vaccine was further undermined by a press report in the German economic newspaper Handelsblatt, which wrongly reported the AZ vaccine was only effective in 8% of the elderly.

This was attributed to a single anonymous government source and has not been supported by any trial data.

An article published by the British Medical Journal last month examined the reasons for the erroneous reporting and uncovered the draft recommendations from German health officials that led to the discredited Handelsblatt story.

UK health leaders suggested the data could lead to a rethink of recommendations about the Oxford vaccine in Germany and other European countries.

Andrew Pollard, professor of paediatric infection and immunity at Oxford Vaccine Group, told BBC Radio: “I think that the scientific committees in each of these countries will be doing exactly that over the days ahead.

“The strength of evidence that we’re now seeing all of that is being accessed by scientific committees in different countries, and I’m sure will help support their decision-making.”

https://pharmaphorum.com/news/data-back-use-of-az-and-pfizer-covid-19-vaccines-in-older-people/

Novavax in talks with FDA over quick approval for COVID-19 shot

 Novavax hopes its COVID-19 vaccine could be filed in the US in the second quarter, following a potential approval from the UK regulator in the coming weeks.

The timetable for approval from the FDA depends on whether the regulator accepts data from the company’s trial in the UK, which could set up a potential Emergency Use Authorisation.

Following an upbeat Q4 results announcement CEO Stanley Erck told CNBC that discussions with the FDA are ongoing but the hope is that the regulator will accept the phase 3 data from the UK showing 96% efficacy against the original COVID-19 variant.

The vaccine also offers some protection against the newer UK and South African variants and is also much easier to distribute and handle than the delicate mRNA vaccines from Moderna and Pfizer/BioNTech, which require ultra-cool storage temperatures.

Novavax’s vaccine is a sequence of protein engineered from the genetic sequence of the SARS-CoV-2 virus that mimics the “Spike” protein found on the pathogen’s surface.

It cannot replicate or cause the disease but does produce a strong immune response that neutralises the virus in the event of an infection.

Novavax’s phase 3 trial in the US is still ongoing with 30,000 participants, but the company hope data already reported from the UK trial will be enough to convince the FDA to approve.

Three regulators – the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), the European Medicines Agency and Health Canada – started rolling reviews of the vaccine at the beginning of February.

This allows them to review trial data as it breaks, vastly speeding up the approval process.

This sets up a potential approval in the UK next month followed by a US filing in May, although the timeline could be pushed by up to two months if the FDA decides to wait for data from the US trial.

Novavax has agreements in place for up to 300 million doses including the UK government, which has 60 million doses of the vaccine on order if approved.

The US biotech will make some of the vaccine at a UK factory in Billingham, Stockton-on-Tees.

Up to 1.1 billion doses could be supplied in a tie-up with the Serum Institute of India to the COVAX scheme aimed at providing access in poorer countries.

There are three COVID-19 vaccines approved in the US, from Moderna, Pfizer/BioNTech and Johnson & Johnson, which was granted an Emergency Use Authorization at the end of last week.

https://pharmaphorum.com/news/novavax-in-talks-with-fda-over-quick-approval-for-covid-19-shot/

Second bump in the road for Arena’s reboot

 Four years after exiting the weight-loss market and selling its obesity drug Belviq to Eisai Arena looks to have rebuilt itself around a pipeline of disparate assets. Yesterday the reboot was set back when the company’s CB2 agonist olorinab failed a phase II trial in abdominal pain due to irritable bowel syndrome. Arena had previously suggested that a 1.5-point placebo-adjusted improvement in pain score in the Captivate study would count as a success; yesterday it gave no data from Captivate, but said there was no statistically significant improvement versus placebo. Abdominal pain is a hallmark of IBS, and there had been hope for the readout given olorinab’s earlier success in a small study in pain associated with Crohn’s disease. Though Arena cited a benefit in a subgroup of Captivate patients with moderate to severe pain at baseline, it accepted that olorinab was now under review for “possible strategic options”, which usually suggests discontinuation. The bad news is that Arena’s lead project, etrasimod, failed in atopic dermatitis last year, and olorinab was supposed to have filled a gap in major catalysts until next year’s phase III etrasimod readout in ulcerative colitis.

Selected Arena pipeline assets
Project	Mechanism	2026e sales ($m)	Use	Detail
Etrasimod	S1P  receptor 1 regulator	950	Atopic dermatitis	Failed ph2 Advise trial
			Crohn's disease	Ph2 Cultivate trial reads out H2 2021
			Ulcerative colitis	Ph3 Elevate trial reads out Q1 2022
Olorinab	CB2 agonist	76	IBD-associated pain	Failed ph2 Captivate trial
Ralinepag	Prostacyclin receptor agonist	50	Pulmonary hypertension	Licensed to United Therapeutics for $800m up front
APD418	Beta 3 adrenoceptor antagonist	–	Heart failure	Said to be in ph1 (no CT.gov entry)
LP352	5-HT2C superagonist	–	Epileptic encephalopathies	Spun out into Longboard Phamacueticals
Source: Arena & EvaluatePharma sellside consensus. https://www.evaluate.com/vantage/articles/news/snippets/second-bump-road-arenas-reboot

Boston Scientific: Buys Surgical Business to Expand Kidney Stone Management

 Boston Scientific Corp. struck a deal to buy the global surgical business of privately held Lumenis Ltd. for a $1.07 billion upfront cash payment in a move to expand its kidney stone management portfolio.

The definitive agreement with an affiliate of Baring Private Equity Asia Ltd., which would retain ownership of Lumenis's global aesthetics and ophthalmology businesses, is subject to closing adjustments, Boston Scientific said Wednesday.

The Lumenis surgical business, with 2021 net sales expected to be about $200 million, includes laser systems, fibers and accessories used for urology and otolaryngology procedures, Boston Scientific said.

The medical-technology company has had a relationship with Israel-based Lumenis for more than 20 years and currently sells the Lumenis urology laser portfolio in the U.S. and Japan through a distribution arrangement. After completing the acquisition, Boston Scientific said it would sell the lasers and fibers, as well as the otolaryngology laser portfolio, to all geographies including high-growth regions such as China.

Boston Scientific said it expects to complete the transaction in the second half of the year, with the impact to its adjusted earnings per share forecast to be immaterial in 2021 but is expected to boost EPS by roughly two cents in 2022 and be increasingly accretive thereafter. Due to amortization expense and acquisition-related net charges, it said the purchase is expected to weigh on earnings this year and then be less dilutive or increasingly accretive thereafter.

https://www.marketscreener.com/quote/stock/BOSTON-SCIENTIFIC-CORPORA-11935/news/Boston-Scientific-nbsp-Buys-Surgical-Business-to-Expand-Kidney-Stone-Management-Portfolio-32592448/

Incyte, Eli Lilly: Baricitinib Meets Main Endpoint in Alopecia Areata Study

 Eli Lilly & Co. and Incyte Corp. on Wednesday said a Phase 3 study evaluating the efficacy and safety of baricitinib met the key goal in the treatment of the autoimmune disorder alopecia areata.

The companies said both the two-milligram and four-milligram once-daily doses in adults with severe alopecia areata met the primary efficacy endpoint at week 36, showing a statistically significant improvement in scalp hair regrowth compared to those on placebo.

There are currently no FDA-approved treatments for alopecia areata, which can cause unpredictable hair loss on the scalp, face and other areas of the body.

Eli Lilly and Incyte said the study marks the first Phase 3 trial with positive results in patients with the disorder, adding that they expect data from an additional Phase 3 study in the first half of the year.

Indianapolis-based Eli Lilly signed an exclusive worldwide license and collaboration agreement with Incyte, a Wilmington, Del., biopharmaceutical company, in late 2009 to develop and commercialize baricitinib and other compounds for inflammatory and autoimmune diseases.

The companies last March received breakthrough-therapy designation from the U.S. Food and Drug Administration for baricitinib for the treatment of alopecia areata.

https://www.marketscreener.com/quote/stock/INCYTE-CORPORATION-9675/news/Incyte-Eli-Lilly-nbsp-Baricitinib-Meets-Main-Endpoint-in-Alopecia-Areata-Study-32592161/

South African scientists say antibodies from variant may offer cross-protection

  Research by South African scientists suggests that antibodies triggered by exposure to the country’s dominant coronavirus variant can prevent infection by other variants, the scientists said on Wednesday.

The findings in laboratory studies offer hope that COVID-19 vaccines based on the 501Y.V2 variant first identified late last year could protect against multiple variants circulating in different parts of the world.

The more contagious variant drove a second wave of infections in South Africa that peaked in January and is believed to have spread to many other countries in Africa and other continents.

“We used plasma ... from people that were infected in this latest wave with the 501Y.V2 and we used it against the first-wave virus, ... what we found is that it could neutralise, OK not as well as it could neutralise itself but it’s not bad at all,” Alex Sigal from the Africa Health Research Institute told a news conference.

Sigal said vaccines designed with the 501Y.V2 variant in mind “might be cross-protective to other variants, ... this gives you some idea how this problem of variants can be solved”.

Penny Moore, a professor at the National Institute for Communicable Diseases, said the antibody response from the 501Y.V2 variant was only reduced threefold against the first-wave virus, whereas the response from the first-wave virus was reduced nine-fold against 501Y.V2.

“It’s not that the antibodies that are triggered by 501Y.V2 are somehow magical, there is a drop-off, ... but unlike the antibodies triggered by the original variant they seem to somehow have a little bit more breadth,” she told the same briefing.

Salim Abdool Karim, a top government adviser on COVID-19, said major vaccine manufacturers including Pfizer, AstraZeneca and Johnson & Johnson were already making vaccines based on the 501Y.V2 variant. Moderna had already adapted its shot and was putting it into human studies, he added.

He predicted that by the end of 2021 most vaccine manufacturers would have adapted their shots, “not because they are specifically worrying about the virus coming from South Africa ... but because key mutations in the 501Y.V2 are actually also present in many other variants”.

Health Minister Zweli Mkhize said the research was encouraging and that genomics surveillance had helped the government respond to the pandemic.

South Africa has recorded by far the most COVID-19 infections and deaths on the African continent, at 1.5 million cases and over 50,000 fatalities to date.

https://www.reuters.com/article/us-health-coronavirus-safrica/south-african-scientists-find-antibodies-from-variant-may-offer-cross-protection-idUSKBN2AV1NI

Telehealth company Ro to offer in-home COVID-19 vaccinations in New York state

 Telehealth company Ro said on Wednesday it was partnering with New York state’s department of health to vaccinate people who can’t leave their homes against COVID-19.

Some elderly, disabled, or otherwise homebound people may face difficulty getting a vaccine that requires them to travel to a mass vaccination site or doctor’s office.

Through the new program, which is initially starting in Yonkers, New York, these patients can make a vaccine appointment online, and a vaccinator will be sent to their home to give them a COVID-19 shot.

Ro said the service was free for the patients and that it would also arrange to cover the transportation costs for the healthcare workers. Uber is partially helping cover these costs through donated free rides, Ro said.

A company spokeswoman said in a pilot version of the program that it recently completed, 90% of patients were non-white, while nearly 60% had incomes lower than $15,000 a year. The average age was 79, she said.

Telehealth companies like Ro have boomed during the pandemic as many patients sought out virtual care for the first time.

Ro began as an online pharmacy selling erectile dysfunction drugs for men, but has since gone on to become a fully fledged telehealth company treating a variety of disorders for men and women.

In 2020, the company acquired Workpath to help it launch in-home care visits for its customers.

In late January, Reuters reported that Ro was exploring a potential deal with a blank-check acquisition company that would value it at more than $4 billion, according to sources familiar with the matter.

The sources said the talks may not lead to a deal and that the company may opt to pursue other options, like another fundraising round.

https://www.reuters.com/article/us-health-coronavirus-vaccines-ro/telehealth-company-ro-to-offer-in-home-covid-19-vaccinations-in-new-york-state-idUSKBN2AV1OU